PRORecalls & reported problems across all models
Stryker GmbH · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 63
- Deaths reported
- 0
- Injuries reported
- 19
- Recalls
- 0
We found 10 models of PRO by Stryker GmbH in the FDA's device registry (GUDID). Together they are named in 63 adverse event reports in the FDA's MAUDE database, received between Jul 30, 2018 and Aug 13, 2026 — classified as 19 injuries, 44 malfunctions.
The most frequently reported specific device problem is “Fracture” (42 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported PRO problems
Device problems
- Fracture42
- Break37
- Adverse Event Without Identified Device or Use Problem7
- Detachment of Device or Device Component2
- Device Slipped2
- Positioning Failure2
- Improper or Incorrect Procedure or Method1
- Material Erosion1
Patient problems
- Foreign Body In Patient29
- No Clinical Signs, Symptoms or Conditions19
- Device Embedded In Tissue or Plaque4
- No Known Impact Or Consequence To Patient4
- Insufficient Information3
- Extraskeletal ossification2
- Necrosis2
- Subluxation2
PRO models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PRO 703966ORTHOPEDIC MANUAL SURGICAL INSTRUMENT49 reports
- PRO 425985SPlate, fixation, bone3 reports
- PRO 425986SPlate, fixation, bone3 reports
- PRO 705461CLAMP2 reports
- PRO 425912SScrew, fixation, bone1 report
- PRO 703976ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- PRO 705464CLAMP1 report
- PRO 705463CLAMP1 report
- PRO 705487ELEVATOR1 report
- PRO 425942SPlate, fixation, bone1 report
Recent PRO adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 13, 2026Fracture
It was reported that, during the procedure the tip of the Stryker drill bit broke off and was retained in the patient's pelvic bone. Patient had a fractured acetabulum following a dirt bike accident and was taken to the operating room for an ORIF (open reduction and internal fixation).
Patient problems: Foreign Body In Patient
MAUDE report 50245093 ↗InjuryJun 8, 2026Fracture
AS REPORTED: "DURING THE PELVIC OPEN REDUCTION AND INTERNAL FIXATION (ORIF) PROCEDURE, IT WAS NOTED THAT WHILE DRILLING THROUGH DENSE BONE, THE TIP OF A DRILL BIT BROKE OFF AND REMAINED INSIDE THE PATIENT."
Patient problems: Foreign Body In Patient
MAUDE report 25429685 ↗InjuryMay 28, 2026Fracture
IT WAS REPORTED THAT, THE BROKEN TIP OF THE DRILL WAS REMAINED TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 25325413 ↗MalfunctionApr 27, 2026Fracture
IT WAS REPORTED THAT, THE DRILL WAS BROKEN. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 25008521 ↗MalfunctionApr 2, 2026Fracture
AS REPORTED: "THE DRILL BIT TIP HAS BROKEN." THE HCP CONFIRMED THAT ALTHOUGH FRAGMENTS WERE PRESENT, THEY HAD ALL BEEN REMOVED AND NONE REMAINED INSIDE THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24769036 ↗InjuryFeb 25, 2026Fracture
AS REPORTED: "THE DRILL BIT FRACTURED DURING THE SURGERY. IT REMAINS WITHIN THE BONE."
Patient problems: Foreign Body In Patient
MAUDE report 24446633 ↗MalfunctionNov 5, 2025Fracture; Fracture
IT WAS REPORTED VIA MEDWATCH MW5175954: DRILL BIT X3 BROKE OFF IN BONE.
Patient problems: Foreign Body In Patient
MAUDE report 23478009 ↗MalfunctionNov 5, 2025Fracture; Fracture
IT WAS REPORTED VIA MEDWATCH MW5175953: DRILL BIT X3 BROKE OFF IN BONE.
Patient problems: Foreign Body In Patient
MAUDE report 23478004 ↗MalfunctionNov 5, 2025Fracture; Fracture
IT WAS REPORTED VIA MEDWATCH MW5175955: DRILL BIT X3 BROKE OFF IN BONE.
Patient problems: Foreign Body In Patient
MAUDE report 23478003 ↗MalfunctionOct 20, 2025Fracture; Fracture
AS REPORTED: "ORIF FOR PELVIC FRACTURE. DRILL FRACTURED DURING DRILLING."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23342579 ↗InjuryAug 28, 2025Break; Fracture; Break; Fracture
AS REPORTED: "DISTRIBUTOR INFORMED SALES REP THAT TWO DRILLS (703966) APPEAR TO HAVE BROKEN DURING SURGERY FOR A PELVIC FRACTURE. SALES REP IS CURRENTLY CONFIRMING THE HEALTH HAZARD TO THE PATIENT AND MEDICAL INTERVENTION, BUT NO FURTHER INFORMATION HAS BEEN PROVIDED BY HCP AT THIS TIME." ADDITIONAL INFORMATION RECEIVED AUGUST 4, 2025. THE DOCTOR REPORTED, ¿THE PATIENT'S BONES WERE VERY HARD, AND DRILLING WAS PERFORMED WITH THE SURROUNDING SOFT TISSUE PUTTING STRESS ON THE DRILL.¿ A BROKEN PIECE OF THE DRILL PENETRATED INTO THE BONE, BUT WAS DIFFICULT TO REMOVE, SO THE PROCEDURE WAS COMPLETED WITH THE BROKEN PIECE LEFT INSIDE THE BODY.
Patient problems: Foreign Body In Patient
MAUDE report 22912506 ↗InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER RECEIVED A STRYKER COLLABORATIVE STUDY (SCS) NAMED "A POST-MARKET CLINICAL EVALUATION OF THE TREATMENT OF PELVIS FRACTURES WITH THE PELVIS NEXT GENERATION PLATES OF THE PRO IMPLANTS SYSTEM" THAT CONTAINS COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF PRO PELVIS NEXT GENERATION IMPLANTS. RETROSPECTIVE ANALYSIS WAS CONDUCTED USING THE CLINIC DOCUMENTS AND RADIOGRAPHIC IMAGES OF CASES AT UAB FROM (B)(6) 2024- (B)(6) 2024. DURING THE REVIEW OF THE REPORT, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE; HOWEVER, THE FOLLOWING ADVERSE EVENT WAS REPORTED: PATIENT 18, 130 DAYS POST-OPERATIVELY, THE SUBJECT DEVELOPED OSSIFICATION, WHICH WAS CLASSIFIED AS MILD AND REMAINS AN ONGOING ISSUE. THIS EVENT WAS POSSIBLY RELATED TO THE DEVICE AND DEFINITELY RELATED TO THE PROCEDURE
Patient problems: Extraskeletal ossification
MAUDE report 22026357 ↗InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER RECEIVED A STRYKER COLLABORATIVE STUDY (SCS) NAMED "A POST-MARKET CLINICAL EVALUATION OF THE TREATMENT OF PELVIS FRACTURES WITH THE PELVIS NEXT GENERATION PLATES OF THE PRO IMPLANTS SYSTEM" THAT CONTAINS COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF PRO PELVIS NEXT GENERATION IMPLANTS. RETROSPECTIVE ANALYSIS WAS CONDUCTED USING THE CLINIC DOCUMENTS AND RADIOGRAPHIC IMAGES OF CASES AT (B)(6) FROM JANUARY 2024- DECEMBER 2024 DURING THE REVIEW OF THE REPORT, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE; HOWEVER, THE FOLLOWING ADVERSE EVENT WAS REPORTED: PATIENT 9 DEVELOPED OSTEOLYSIS, ARTHRITIS, AND BONE FRACTURES ASSOCIATED WITH POST-TRAUMATIC OSTEOARTHRITIS AT 209 DAYS POST-OPERATIVELY. THIS EVENT WAS CATEGORIZED AS MODERATE AND IS STILL ONGOING WITHOUT NECESSITATING REVISION SURGERY. THE RELATIONSHIP TO BOTH THE DEVICE AND PROCEDURE WAS CONSIDERED POSSIBLY RELATED.
Patient problems: Arthritis; Bone Fracture(s); Osteolysis
MAUDE report 22026305 ↗InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER RECEIVED A STRYKER COLLABORATIVE STUDY (SCS) NAMED "A POST-MARKET CLINICAL EVALUATION OF THE TREATMENT OF PELVIS FRACTURES WITH THE PELVIS NEXT GENERATION PLATES OF THE PRO IMPLANTS SYSTEM" THAT CONTAINS COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF PRO PELVIS NEXT GENERATION IMPLANTS. RETROSPECTIVE ANALYSIS WAS CONDUCTED USING THE CLINIC DOCUMENTS AND RADIOGRAPHIC IMAGES OF CASES AT UAB FROM JANUARY 2024- DECEMBER 2024 DURING THE REVIEW OF THE REPORT, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE; HOWEVER, THE FOLLOWING ADVERSE EVENT WAS REPORTED: PATIENT EXPERIENCED OSSIFICATION 103 DAYS POST-OPERATIVELY, CLASSIFIED AS MILD, AND REMAINS AN ONGOING ISSUE WITHOUT REQUIRING REVISION SURGERY. THIS ADVERSE EVENT WAS CONSIDERED POSSIBLY RELATED TO THE DEVICE AND DEFINITELY RELATED TO THE PROCEDURE.
Patient problems: Extraskeletal ossification
MAUDE report 22025369 ↗InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER RECEIVED A STRYKER COLLABORATIVE STUDY (SCS) NAMED "A POST-MARKET CLINICAL EVALUATION OF THE TREATMENT OF PELVIS FRACTURES WITH THE PELVIS NEXT GENERATION PLATES OF THE PRO IMPLANTS SYSTEM" THAT CONTAINS COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF PRO PELVIS NEXT GENERATION IMPLANTS. RETROSPECTIVE ANALYSIS WAS CONDUCTED USING THE CLINIC DOCUMENTS AND RADIOGRAPHIC IMAGES OF CASES AT UAB FROM JANUARY 2024- DECEMBER 2024. DURING THE REVIEW OF THE REPORT, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE; HOWEVER, THE FOLLOWING ADVERSE EVENT WAS REPORTED: PATIENT 15 WAS DIAGNOSED WITH FEMORAL HEAD NECROSIS AT 45 DAYS POST-OPERATIVELY. THIS ADVERSE EVENT WAS CATEGORIZED AS SEVERE BUT DID NOT REQUIRE REVISION SURGERY AT THE TIME OF REPORTING. THE EVENT WAS DETERMINED TO BE POSSIBLY RELATED TO BOTH THE DEVICE AND THE PROCEDURE AND REMAINS ONGOING. THIS PATIENT IS SCHEDULED FOR A THA IN THE NEAR FUTURE.
Patient problems: Necrosis
MAUDE report 22019790 ↗
Other Stryker GmbH products
All Stryker GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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